We are GROWING! Manager, Operations (Cleaning & Sterilization)

Role: Operations Manager overseeing the newly established Cleaning & Sanitation department at Axogen, with primary responsibilities in managing daily operations, ensuring compliance with cGMP and FDA regulations, and driving continuous improvement initiatives. Responsibilities include staffing, training, safety, quality assurance, process development, and cross-functional collaboration with Quality, R&D, and other departments. Requirements: minimum 5 years in operations or QA within medical device, pharmaceutical, or biotech manufacturing; 3+ years of leadership or project management; Bachelor's in Life Science or Engineering; strong knowledge of cGMP, FDA, and regulated environments; leadership, communication, and problem-solving skills. Preferred: experience with biologics, tissue processing, or sterile manufacturing, and familiarity with lean, Six Sigma, or DMAIC methodologies. High-value: leading tissue biologic production, cGMP compliance, regulatory support (FDA, ISO, AATB), and managing operational metrics related to safety, quality, and productivity. Work setup: based in Vandalia, OH, with at least 10% travel required.